ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM— 510(k) K023561
Substantially EquivalentInternational Technidyne Corp.
FDA 510(k) clearance K023561 for ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM, Substantially Equivalent on 2003-01-31. Applicant: International Technidyne Corp.. Device class: 2.
Clearance details
- Applicant
- International Technidyne Corp.
- Product code
- Code GKR
- Device class
- Class 2
- Regulation
- 21 CFR 864.5620
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edison, NJ, US
Recent devices under product code GKR
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